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Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656

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ClinicalTrials.gov Identifier: NCT02599792
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Brief Summary:
Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.

Condition or disease Intervention/treatment Phase
Healthy Drug: CTP-656 Drug: Placebo for CTP-656 Drug: Kalydeco Phase 1

Detailed Description:
This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Two-Part Phase 1 Healthy Volunteer Study: A Crossover Comparison of CTP-656 Solid Dose Formulation vs. Kalydeco® and a Double-Blind, Placebo-Controlled, Ascending Multiple Dose Evaluation of CTP-656
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ivacaftor

Arm Intervention/treatment
Experimental: CTP-656, 150 mg
Single Oral Dose
Drug: CTP-656
Active Comparator: Kalydeco, 150 mg
Single oral dose
Drug: Kalydeco
Experimental: CTP-656, 75 mg or matching placebo
Subjects will be administered 75 mg CTP-656 for 7 days.
Drug: CTP-656
Drug: Placebo for CTP-656
Experimental: CTP-656, 150 mg or matching placebo
Subjects will be administered 150 mg CTP-656 for 7 days.
Drug: CTP-656
Drug: Placebo for CTP-656
Experimental: CTP-656, high dose or matching placebo
Subjects will be administered up to 300 mg CTP-656 for 7 days.
Drug: CTP-656
Drug: Placebo for CTP-656



Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 7 days ]
    adverse events categorized by body system and MedDRA term

  2. Measure exposure of test articles using area under the concentration time curve (AUC) [ Time Frame: 96 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults between 18 and 50 years of age, inclusive
  • Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria:

  • History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
  • PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug
  • Liver function tests greater than the upper limit of normal.
  • Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
  • Urinalysis positive for greater than trace blood, protein or glucose
  • A positive screen for alcohol, drugs of abuse, or tobacco use.
  • Inability to comply with food and beverage restrictions during study participation.
  • Donation or blood collection or acute loss of blood prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599792


Locations
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Australia, South Australia
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
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Study Director: Lana Pilja Concert Pharmaceuticals, Inc.

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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02599792     History of Changes
Other Study ID Numbers: CP656.1002
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

Keywords provided by Concert Pharmaceuticals:
Safety and Pharmacokinetics

Additional relevant MeSH terms:
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Ivacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action